GUEST COLUMNISTS

• The Promise Of Outcomes-Based Agreements For Cell & Gene Therapies

  There is a pressing need for stakeholders to find cost-effective ways to help more patients gain access to cell and gene therapies. While many types of innovative payment models exist, outcomes-based agreements — in which manufacturers and payers agree to specific performance and outcome metrics — are emerging as an attractive best practice option for both parties.

• The Holistic Guide To Supply Chain For Cell & Gene Therapy Startups

  How does the cell and gene therapy supply chain team stay ahead of the expected changes and respond at the speed the developing program expects? Supplier selection, raw materials, built-in quality, warehousing and logistics, and traceability are all covered in this article.

• EMA's Revised GMP Annex 1 Addresses Common Global Challenges for Sterile Products

  The new EMA GMP Annex 1, “Manufacture of Sterile Medicinal Products," is in line with other international regulations, e.g., ICH and PIC/S. FDA involvement in its writing is a clear indication that the contents will be the FDA position in general terms. Fortunately, the annex contains many checklists to help you assess and remedy your systems.

• FDA Releases Final Guidance On Early-Phase Cell & Gene Therapy Trials

  The cell and gene therapy development process involves screening different variants of a product type. To aid this process and to ensure that suitable evidence is gathered so that effective variants of the product are taken through to later-stage trials, the FDA has produced a final guidance, Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial.

• Revision Of The ASTM E3263 Standard For Visual Inspection Of Pharmaceutical Manufacturing Equipment And Medical Devices For Residues

  ASTM has published the revision of ASTM E3263 "Standard Practice For Qualification Of Visual Inspection Of Pharmaceutical Manufacturing Equipment And Medical Devices For Residues.” This article, written by the ASTM revision team itself, explains the reasons behind the revision and delves into the key updates.

• The Best CDMOs Are Redundant

  The top CDMO-selection criteria for Perry Calias, Chief Operations Officer, Revolo Biotherapeutics, and a veteran outsourcer, is redundancy. Redundancy laced with relationships, that is. Here's how it can work for you.

• Defining The RNA Therapeutics Industry In 2023

  Four executives outline which industry challenges, strategic considerations, and opportunities should be top of mind as RNA therapeutics companies establish their to-do lists for 2023.

• Frequent Deficiencies In GMP Inspections, Part 3

  Don't let cleaning and disinfection methods work against you. Without a system to track cleaning chemicals and equipment, how do you know they haven't expired?